Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Recalled by St. Jude Medical, Cardian Rhythm Management Division Due to Due to a manufacturing issue associated with the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical, Cardian Rhythm Management Division directly.
Affected Products
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Quantity: 242,945 pacemakers [updated 3/20/2023]
Why Was This Recalled?
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About St. Jude Medical, Cardian Rhythm Management Division
St. Jude Medical, Cardian Rhythm Management Division has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report